(306 days)
The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
The PSM LOMAS / BENEFIT Screws are made of Titanium alloy. The bone screws are designed to be used transmucosally for osseous orthodontic anchorage. They are used as Temporary Anchorage Devices (TAD) for orthodontic treatments. The LOMAS screws (Ø1.5 mm and 2.0 mm), as well as the BENEFIT screws (Ø2.0mm and 2.3mm) come in two diameters and all screws come in five lengths (7 mm, 9 mm, 11 mm, 13 mm, and 15 mm). The screws are divided in five groups of screws, LOMAS Standard, LOMAS Quattro, LOMAS Quattro V and BENEFIT Screws. The range of providing flexibility for specific orthodontic applications. The screws consist of either three or four components: head, platform, body (thread) or moreover neck.
The provided text describes a 510(k) summary for PSM LOMAS / BENEFIT Screws, a type of orthodontic mini-anchor system. It details the device description, indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, the document does not provide specific acceptance criteria or details about a study proving the device meets those criteria.
The "Performance data" section only lists the types of tests performed:
- Breakage and Fatigue Tests
- Material Tests
- Validation Tests of sterile barrier system and packaging system
- Sterilization Validation Tests
- Microbiological Test for determination of microorganisms
- Several Clinical Justifications and Studies
It does not provide:
- A table of acceptance criteria and the reported device performance: The document mentions tests were performed but does not list specific criteria or the results against them.
- Sample size used for the test set and the data provenance: This information is not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present, as no specific performance study with a test set is detailed.
- Adjudication method for the test set: Not applicable as a performance study involving a test set and ground truth is not detailed.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable for this type of medical device (physical screw vs. diagnostic AI).
- If a standalone performance study was done: The document states "Several Clinical Justifications and Studies" were performed but does not describe the methodology or results of any such standalone study.
- The type of ground truth used: Not applicable as specific performance studies involving ground truth are not detailed.
- The sample size for the training set: Not applicable as this is not an AI/ML device where a training set would be relevant in the traditional sense. The "training" here would be related to engineering design and material science.
- How the ground truth for the training set was established: Not applicable.
In summary, the document states that various tests and studies were performed to support substantial equivalence but does not provide the detailed information requested regarding specific acceptance criteria and the evidence proving the device meets them. The filing primarily relies on demonstrating equivalence to predicate devices based on technical characteristics, indications for use, material, target population, performance, safety, effectiveness, and biocompatibility.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.